Download or read book GMP ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers Volume 1 With Checklists and Software Package written by Leonard Steinborn and published by CRC Press. This book was released on 2019-04-23 with total page 633 pages. Available in PDF, EPUB and Kindle. Book excerpt: Volume 1 of this two-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these
Download or read book Quality Systems Handbook written by David Hoyle and published by Elsevier. This book was released on 2015-08-11 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Systems Handbook is a reference book that covers concepts and ideas in quality system. The book is comprised of two parts. Part 1 provides the background information of ISO 9000, such as its origin, composition, application, and the strategies for registration. Part 2 covers topics relevant to the ISO 9000 requirements, which include design control, internal quality audits, and statistical techniques. The text will be useful to managers, auditors, and quality practitioners who require reference in the various aspects of quality systems.
Download or read book Control of Particulate Matter Contamination in Healthcare Manufacturing written by Thomas A. Barber and published by CRC Press. This book was released on 1999-10-31 with total page 579 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an expert in the industry, this text addresses the specifics of contamination, including particle origination, characterization, identification, and elimination, with a special focus on quality. The author offers a clear and concise review of particle populations and their control in stability, efficacy, and predictability in the manufacture of healthcare products. He brings together information from over 100 Web sites and other sources and casts it into a practical framework that will help readers ensure their company's success. The book contains thirty-two color photomicrographs and over eighty figures, tables, and charts.
Download or read book Thomas Register of American Manufacturers and Thomas Register Catalog File written by and published by . This book was released on 2002 with total page 1870 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vols. for 1970-71 includes manufacturers' catalogs.
Download or read book Quality Systems and Standards for a Competitive Edge written by and published by World Bank Publications. This book was released on 2007 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book responds to the challenge of providing a comprehensive account of quality systems for private sector development: what works and what doesnt on the ground, and why. This volume provides a thorough analysis of the diversity of institutions, linkages, and arrangements involved in quality systems, identifying success factors in countries quality strategies. It explains why quality and standards matter for export growth, for productivity, for industrial upgrading, and for diffusion of innovation, all central ingredients in improving economic growth and generating real gains in poverty reduction. It provides a detailed blue print for implementing effective National Quality Systems. Quality and Standards Matter is a valuable tool for policymakers confronted with the challenges of building trade competitiveness in the new global economy.
Download or read book Thomas Register of American Manufacturers written by and published by . This book was released on 2002 with total page 1944 pages. Available in PDF, EPUB and Kindle. Book excerpt: This basic source for identification of U.S. manufacturers is arranged by product in a large multi-volume set. Includes: Products & services, Company profiles and Catalog file.
Download or read book PRODUCTS SERVICES written by and published by . This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Dictionary of Pharmaceutical Medicine written by Gerhard Nahler and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places
Download or read book Food Processing Technology written by P.J. Fellows and published by Elsevier. This book was released on 2009-06-22 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first edition of Food processing technology was quickly adopted as the standard text by many food science and technology courses. This completely revised and updated third edition consolidates the position of this textbook as the best single-volume introduction to food manufacturing technologies available. This edition has been updated and extended to include the many developments that have taken place since the second edition was published. In particular, advances in microprocessor control of equipment, 'minimal' processing technologies, functional foods, developments in 'active' or 'intelligent' packaging, and storage and distribution logistics are described. Technologies that relate to cost savings, environmental improvement or enhanced product quality are highlighted. Additionally, sections in each chapter on the impact of processing on food-borne micro-organisms are included for the first time. - Introduces a range of processing techniques that are used in food manufacturing - Explains the key principles of each process, including the equipment used and the effects of processing on micro-organisms that contaminate foods - Describes post-processing operations, including packaging and distribution logistics
Download or read book HACCP in Meat Poultry and Fish Processing written by A. M. Pearson and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: The RACCP (hazard analysis critical control point) concept for food products was an outgrowth of the US space program with the demand for a safe food supply for manned space flights by the National Aeronautics and Space Administration (NASA). The original work was carried out by the Pillsbury Company under the direction of Roward E. Bauman, who as the author of chapter 1 describes the evolution of the RACCP system and its adaptation to foods. The second chapter discusses the adoption of RACCP principles and explains how they fit into the USDA and FDA meat, poultry and seafood inspection systems. The next chapter discusses how RACCP principles can be extended to production of meat, poultry and seafoods, a most important area involved in producing a safe food supply. Chapter 4 deals with the use of RACCP in controlling hazards encountered in slaughtering and distribution of fresh meat and poultry, while chapter 5 discusses the problem - both spoilage and hazards - involved in processing and distribution of meat, poultry and seafood products. Chapter 6 covers the entire area of fish and seafoods, including both fresh and processed products from the standpoints of spoilage and hazards.
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Download or read book Handbook of Electrical Engineering written by Alan L. Sheldrake and published by John Wiley & Sons. This book was released on 2016-06-22 with total page 650 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical treatment of power system design within the oil, gas, petrochemical and offshore industries. These have significantly different characteristics to large-scale power generation and long distance public utility industries. Developed from a series of lectures on electrical power systems given to oil company staff and university students, Sheldrake's work provides a careful balance between sufficient mathematical theory and comprehensive practical application knowledge. Features of the text include: Comprehensive handbook detailing the application of electrical engineering to the oil, gas and petrochemical industries Practical guidance to the electrical systems equipment used on off-shore production platforms, drilling rigs, pipelines, refineries and chemical plants Summaries of the necessary theories behind the design together with practical guidance on selecting the correct electrical equipment and systems required Presents numerous 'rule of thumb' examples enabling quick and accurate estimates to be made Provides worked examples to demonstrate the topic with practical parameters and data Each chapter contains initial revision and reference sections prior to concentrating on the practical aspects of power engineering including the use of computer modelling Offers numerous references to other texts, published papers and international standards for guidance and as sources of further reading material Presents over 35 years of experience in one self-contained reference Comprehensive appendices include lists of abbreviations in common use, relevant international standards and conversion factors for units of measure An essential reference for electrical engineering designers, operations and maintenance engineers and technicians.
Download or read book Haccp in the Meat Industry written by M. Brown and published by Elsevier. This book was released on 2000-09-22 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: The recent outbreaks of E.coli and BSE have ensured that the issue of meat safety has never had such a high profile. Meanwhile HACCP has become the preferred tool for the management of microbiological safety. Against a background of consumer and regulatory pressure, the effective implementation of HACCP systems is critical. Written by leading experts in the field, HACCP in the meat industry provides an authoritative guide to making HACCP systems work effectively.This book examines the HACCP in the meat industry across the supply chain, from rearing through to primary and secondary processing.
Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
Download or read book Trends in Development of Medical Devices written by Prakash Srinivasan Timiri Shanmugam and published by Academic Press. This book was released on 2020-01-25 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. - Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows - Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations - Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities
Download or read book Medical Textile Materials written by Yimin Qin and published by Woodhead Publishing. This book was released on 2015-11-21 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Textile Materials provides the latest information on technical textiles and how they have found a wide range of medical applications, from wound dressings and sutures, to implants and tissue scaffolds. This book offers a systematic review of the manufacture, properties, and applications of these technical textiles. After a brief introduction to the human body, the book gives an overview of medical textile products and the processes used to manufacture them. Subsequent chapters cover superabsorbent textiles, functional wound dressings, bandages, sutures, implants, and other important medical textile technologies. Biocompatibility testing and regulatory control are then addressed, and the book finishes with a review of research and development strategy for medical textile products. - Provides systematic and comprehensive coverage of the manufacture, properties, and applications of medical textile materials - Covers recent developments in medical textiles, including antimicrobial dressings, drug-releasing materials, and superabsorbent textiles - Written by a highly knowledgeable author with extensive experience in industry and academia
